BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 15052417 · Received July 19, 2022

    Report

    Report Number
    3008114965-2022-00496
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    July 8, 2022
    Report Date
    September 7, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075363
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING THE PROCEDURE AND BEFORE RELEASING THE STENT OF A 4MM X 23MM ENTERPRISE2 (ENCR402312, 6812672), THE PHYSICIAN OBSERVED POSITION OF THE STENT WAS NOT IDEAL. THEN THE DOCTOR RETRACTED THE STENT INTO THE UNSPECIFIED MICROCATHETER, BUT IT WAS FOUND THAT THE STENT WAS RELEASED IN THE MICROCATHETER WITHOUT EXPECTATION. A NEW DEVICE WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT RESISTANCE WAS FELT WITHIN THE MICROCATHETER. THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. A NON-STERILE ENTERPRISE2 4MMX23MM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND ONLY THE DELIVERY WIRE AND THE INTRODUCER WERE RETURNED FOR EVALUATION, BOTH WERE FOUND TO BE IN GOOD CONDITIONS (I.E., NO KINKS, NO FRACTURES, OR SEPARATIONS). THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED BECAUSE THE STENT WAS NOT RETURNED FOR EVALUATION WITH THE REST OF THE DEVICE. THE STENT MUST BE STILL INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ALTHOUGH THE MICROCATHETER WAS NOT RETURNED TO VERIFY IF THE STENT IS REMAINS INSIDE IT, THE DETACHED CONDITION OF THE STENT IS RELATED TO THE CUSTOMER COMPLAINT REGARDING A PREMATURE DETACHMENT. BASED ON THE RESULTS OF THE ANALYSIS THE CUSTOMER COMPLAINT WAS CONFIRMED. THE CUSTOMER COMPLAINTS REGARDING A RESISTANCE/FRICTION CONDITION WAS NOT ABLE TO BE EVALUATED SINCE THE STENT WAS NOT RETURNED FOR ANALYSIS AND A FUNCTIONAL TEST COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. IF RESISTANCE IS FELT WHILE RECAPTURING THE STENT, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE INFUSION CATHETER SLIGHTLY TO UNSHEATHE THE STENT (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE STENT AGAIN. ASSIGNMENT OF ROOT CAUSE FOR THE EVENTS REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURES AND DAMAGES ON THE RETURNED SYSTEM. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3 AND H10. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING THE PROCEDURE AND BEFORE RELEASING THE STENT OF A 4MM X 23MM ENTERPRISE2 (ENCR402312, 6812672), THE PHYSICIAN OBSERVED POSITION OF THE STENT WAS NOT IDEAL. THEN THE DOCTOR RETRACTED THE STENT INTO THE UNSPECIFIED MICROCATHETER, BUT IT WAS FOUND THAT THE STENT WAS RELEASED IN THE MICROCATHETER WITHOUT EXPECTATION. A NEW DEVICE WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT RESISTANCE WAS FELT WITHIN THE MICROCATHETER. THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528113 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL ENF402300 6812672 10886704075363

    Patients

    Seq Age Sex Outcome Treatment
    1 Male UNSPECIFIED MICROCATHETER